Puesto CRA II / Senior
- Perform site visits and monitor activities in accordance with protocol, GCP/ICH
Guidelines, and applicable regulatory requirements, from SIV to SCV (phase I-IV)
- Collaborate on procedures development, and query resolution.
- Review and verify case report forms and other clinical data for completeness and
- Generate queries and manage resolutions with site staff.
- Maintain project tracking systems as required.
- Use expertise to identify and resolve complex site issues and deficiencies in
documentation, communication, and the need for additional training.
- Identify protocol deviations or major risks to data integrity.
- Provide recommendations regarding site-specific actions.
- Act as a liaison between the company and study site personnel and be able to
respond to site concerns and questions.
Puesto Clinical Trials Projects Manager
- Project Plan development and control
- Project documents development (e.g.: Protocol, PIS, Investigator and Central Trial Master
- Start-up process management including finance and legal aspects.
- Project control: documents, study procedures, IMP, monitoring and financing
- Prepare projects documents for internal and external audits/inspections.
- Generate, deliver and control project reports.
- Collaboration in project data management.
- Collaboration on scientific manuscripts edition and submission for publication